XerosisPhase 2/3NCT02429206
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
A Phase 2/3 study testing SQIN and standard moisturizing cream (Glaxal Base) in people with Xerosis, run by Nordic Life Science Pipeline Inc. at 1 site in Canada.
Trial summary
In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xerosis
- What is being tested?
- SQIN and standard moisturizing cream (Glaxal Base)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jun 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
- Chronically injured (at least 3 months post-injury)
- Paraplegic or tetraplegic
- 18-75 years of age
- Men and women
- French-speaking
Who cannot join
- Acute or subacute stage (within 1 day and 3 months post-injury)
- Had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years
- Allergic or hypersensitive to any ingredient, investigational or control product
- With psychiatric or mental disorder(s)
- Children (younger than 18 year-old) or elderly (older than 75 year-old)
- Not French-speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Double Blind, Randomized Phase II/III Study to Assess the Safety and Efficacy of SQIN™ on Xerosis in Adults Suffering of Mobility Impairment and/or Complete Paralysis Associated With Chronic Spinal Cord Injury.
In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.
Read the detailed description
Xerosis is a medical term for dry skin. When it results in skin that is scaly and itchy, the condition is called pruritus. This occurs when natural moisture is drawn out of the skin. The skin needs moisture to protect itself. The best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers. However, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones). SQIN with CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects. Based upon preliminary evidence, SQIN with CanSATs technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.
- Conditions
- Xerosis
- Being tested
- SQIN, standard moisturizing cream (Glaxal Base)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQINOther
Also called SQIN on one side - control cream on other side
Each patient will be asked to self-apply both creams (experimental vs positive control) on the right and left sides of their body (sides will be randomly assigned).
standard moisturizing cream (Glaxal Base)Other
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | Each volunteer will be asked to self-apply a standard moisturizing cream (Glaxal Base) on one side of their body. Application twice a day during 14 days. Receives: Other: standard moisturizing cream (Glaxal Base) |
| Experimental Cream | Experimental | Each volunteer will be asked to self-apply the experimental product (SQIN with CanSATs technology) on the other side of their body. Application twice a day during 14 days. Receives: Other: SQIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin tolerance (Self-assessment of redness or itchiness problems)
Self-assessment of redness or itchiness problems during or after the treatment
Measured: 14 days
Moisturizing level (Self-assessment (5-level score)
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
Measured: 14 days
Elasticity level (Self-assessment (5-level score)
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Life Science Pipeline Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Guertin, Ph.D., Study director, Nordic Life Science Pipeline and Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429206
- Sponsor's protocol ID
- SQIN-01
- Status last verified
- Aug 2015
- First submitted
- 17 Apr 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blind, Randomized Phase II/III Study to Assess the Safety and Efficacy of SQIN™ on Xerosis in Adults Suffering of Mobility Impairment and/or Complete Paralysis Associated With Chronic Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT02429206
- Acronym / sponsor ID
- SQIN-01
- Conditions
- Xerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nordic Life Science Pipeline Inc.University, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.
Detailed description
Xerosis is a medical term for dry skin. When it results in skin that is scaly and itchy, the condition is called pruritus. This occurs when natural moisture is drawn out of the skin. The skin needs moisture to protect itself. The best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers. However, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones). SQIN with CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects. Based upon preliminary evidence, SQIN with CanSATs technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Other: standard moisturizing cream (Glaxal Base)Each volunteer will be asked to self-apply a standard moisturizing cream (Glaxal Base) on one side of their body. Application twice a day during 14 days. |
| Experimental Cream | Experimental | Other: SQINEach volunteer will be asked to self-apply the experimental product (SQIN with CanSATs technology) on the other side of their body. Application twice a day during 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
- Chronically injured (at least 3 months post-injury)
- Paraplegic or tetraplegic
- 18-75 years of age
- Men and women
Key exclusion criteria (6 listed)
- Acute or subacute stage (within 1 day and 3 months post-injury)
- Had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years
- Allergic or hypersensitive to any ingredient, investigational or control product
- With psychiatric or mental disorder(s)
- Children (younger than 18 year-old) or elderly (older than 75 year-old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQINAlso: SQIN on one side - control cream on other sideEach patient will be asked to self-apply both creams (experimental vs positive control) on the right and left sides of their body (sides will be randomly assigned). | Other | Experimental Cream |
| standard moisturizing cream (Glaxal Base) | Other | Positive Control |
Primary outcome
Skin tolerance (Self-assessment of redness or itchiness problems)
Time frame: 14 days
Self-assessment of redness or itchiness problems during or after the treatment
Moisturizing level (Self-assessment (5-level score)
Time frame: 14 days
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
Elasticity level (Self-assessment (5-level score)
Time frame: 14 days
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
Related trials for Xerosis
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Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
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Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
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Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
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Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Xerosis Cutis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Guertin, Ph.D. study director
Nordic Life Science Pipeline and Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SQIN and standard moisturizing cream (Glaxal Base) in people with Xerosis, run by Nordic Life Science Pipeline Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin tolerance (Self-assessment of redness or itchiness problems) (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.